Nasal Mask Ventilation During the Induction of General Anesthesia

NCT01651286 | Completed

• 1 other identifier: 2011P001283
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, the investigators demonstrated that nasal route ventilation is superior to the nasal-oral combined ventilation in the absence of jaw thrust and chin up maneuvers. The investigators hypothesize nasal mask ventilation may reduce the incidence of difficult mask ventilation during the induction of general anesthesia by: 1) producing a better seal than full face mask, and 2)establishing a greater airway patency and more effectively ventilate than full face mask ventilation. The investigators intend to test this hypothesis on adult patients during the induction of general anesthesia in the absence of muscle relaxation.

Conditions

Mechanical Ventilation Complication; Upper Airway Obstruction

Keywords

General anesthesia; Positive-pressure ventilation; Masks

Outcome Measures

Primary Outcomes (1)

• Tidal volume

  Tidal volume generated by the positive pressure ventilation during the induction of general anesthesia

  in 30 minutes after the induction of general anesthesia

Secondary Outcomes (2)

• Carbon dioxide removal

  in 30 minutes after the induction of general anesthesia

• success rate of positive pressure ventilation with different masks

  in 30 minute after the induction of general anesthesia

Study Arms (2)

nasal mask

EXPERIMENTAL

when the patient is apneic after the injection of anesthetics in the operating room, a nasal mask will be applied with positive pressure ventilation for 1 min. Then the nasal mask will be replaced with a full face mask for 1 min. Subsequently, the face mask will be replaced with the nasal mask.

Procedure: nasal mask; Procedure: full face mask

full face mask

ACTIVE COMPARATOR

when the patient is apneic after the injection of anesthetics in the operating room, a full face mask will be applied with positive pressure ventilation for 1 min. Then the full face mask will be replaced with a nasal mask for 1 min. Subsequently, the nasal mask will be replaced with the full face mask.

Procedure: nasal mask; Procedure: full face mask

Interventions

nasal mask PROCEDURE

Using the nasal mask instead of the full face mask during the induction of general anesthesia

full face mask; nasal mask

full face mask PROCEDURE

using a standard full face mask during the induction of general anesthesia.

full face mask; nasal mask

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• ASA physical status classification I-II
• general anesthesia
• elective surgery
• who are able to breathe through both their nose and mouth while awake

You may not qualify if:

• Patients with major cardiovascular disease, respiratory disease, cerebral vascular disease or American Society of Anesthesiologists physical status class III or greater.
• Abnormal vital signs on the day of admission for surgery \[heart rate (HR, \>100 bpm or \<40 bpm), blood pressure (BP, \>180/100 mmHg or \<90/60 mmHg), room air transcutaneous oxyhemoglobin saturation (SPO2) \<96%\] that are not correctable with his or her routine medication or commonly used pre-operative medication.
• Unable to open mouth (\<2.5 cm) or unable to breathe through their mouth or nose.
• Any person with an anticipated difficult airway. This will include subjects that require or may require either a fiberoptic intubation or intubation while awake.
• Gastric-esophageal reflex or a full stomach.
• Neurological symptoms associated with neck extension, a neurological deficit from a previous stroke or spinal cord injury, a recent stroke or Transient Ischemic Attack (TIA) within 2 weeks.
• Pregnant women and women less than one month post-partum. Ruling out pregnancy will be conducted by careful history and physical examination as performed routinely prior to surgery. If the history is believed to be unreliable, the patient will be excluded unless a pregnancy test is performed and the result of the test is negative.
• Emergency cases and subjects who have not adhered to the ASA NPO (Nil Per Os - Nothing By Mouth) guidelines.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Hovig V Chitilian, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Yandong Jiang, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: July 27, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

US (1)